Hot Melt Extrusion

Hot Melt Extrusion (HME) is a widely applied technology in the plastics industry. An increasingly explored technology in the pharmaceutical industry, HME has proven to be a robust and viable method for pharmaceutical applications capable of creating a diverse range of dosage forms with clinical benefits.

HME is the process of embedding drug in a thermoplastic carrier. The mixture is processed at elevated temperatures and pressures, which disperses the drug in the matrix at a molecular level to form a solid solution. Extruded material can be further processed into a variety of dosage forms, including capsules, tablets and transmucosal systems. HME is an efficient platform for the production of amorphous solid dispersions to enhance the bioavailability of poorly soluble compounds. HME is suitable for both low and high-potent compounds and has been demonstrated to provide sustained, modified and immediate release profiles. These applications demonstrate the potential of HME as a drug delivery processing technology.

Hot Melt Extrusion Expertise

Formex’s extensive experience applying HME techniques to drug delivery has made Formex a recognized world-leader in formulating molecules using HME. Formex’s scientists have authored numerous peer reviewed articles, presentations and book chapters on the topic and are listed as co-inventors on approved US patents related to HME. Formex is one of a few contract development organizations capable of taking a drug candidate from formulation development to GMP manufacturing utilizing HME. Formex’s experience with and integrated approach to HME formulation and process development ensures the most rapid and cost effective route to the clinic.